CORDIS fornisce collegamenti ai risultati finali pubblici e alle pubblicazioni dei progetti ORIZZONTE.
I link ai risultati e alle pubblicazioni dei progetti del 7° PQ, così come i link ad alcuni tipi di risultati specifici come dataset e software, sono recuperati dinamicamente da .OpenAIRE .
Risultati finali
Update website with Pyrapreg extension overview and consortium; website will subsequently be updated in M3, 6, 9 and 12.
Meetings + minutes (either through monthly teleconference of face-to-face meetings) to monitor the implementation and progress of the project
Organization and minuting of DSMB meetings
Final Stewardship Plan (si apre in una nuova finestra)Stewardship plans outline how to achieve the optimal use of an intervention, including, for example, how to avoid irrational use, overuse or abuse of health technologies.” A final plan will be made availabe in M12
Clinical Trial Report (si apre in una nuova finestra)This is the report of the clinical activities and will include the end of follow up report of both mothers and infants.
Stewardship plan (si apre in una nuova finestra)Stewardship plans outline how to achieve the optimal use of an intervention, including, for example, how to avoid irrational use, overuse or abuse of health technologies.” A draft plan will be made available in M6.
Updated plan for the exploitation and dissemination of results including communication activities (si apre in una nuova finestra)We will reassess our previous developed Plan for the exploitation and dissemination of results including communication activities for compliance with Horizon Europe requirements. An updated version will be available at M6
Collection of documents related to the status of the clinical trial (si apre in una nuova finestra)deliverable Provision of EDCTP2 project documents to be shared as background information. These include:-Initial study package of Pyrapreg-Final version of study protocol-Ethical approvals-Data and Safety Monitoring Board reports-Publications
Master Degrees (2) (si apre in una nuova finestra)Two Masters students have completed their training.
Maternal Safety Report (si apre in una nuova finestra)Report on maternal AE, AESI and SAE
Networking Progress Report (si apre in una nuova finestra)List of updates in the dissemination tools.
PhD Degrees (2) (si apre in una nuova finestra)Two PhD students have completed their PhD training
Trail Steering Committee (TSC) meetings (si apre in una nuova finestra)Organization and minuting of TSC meetings
Updated Data Management Plan (si apre in una nuova finestra)The MRC-The Gambia of LSTMH is responsible for the data management of the project. A data management plan (DMP) has been put in place under EDCTP 2. An updated DMP will be made available at M6.
Study final report (si apre in una nuova finestra)This is the overall report of the entire study including all the different work packages.
Final report (si apre in una nuova finestra)Report describing the final outcomes of the project as per EU regulations
Population PK Report (si apre in una nuova finestra)Summary report on the population PK and PKPD modelling of pyronaridine in pregnant and non-pregnant malaria patients, including pregnancy effects and exposure-response analysis
Report on the status of posting results (si apre in una nuova finestra)Report on the posting of summary trial results in the applicable registry/ies (where the study was registered).
Infant Safety Report (si apre in una nuova finestra)Safety outcome after one year.
Global Access Plan (si apre in una nuova finestra)Proportional global access plan describing potential registration and access items
Ethics Advisor: An external independent ethics advisor needs to be appointed to advise the project participants on ethics issues, in particular the need to address ethical risks related to the involvement of vulnerable populations (pregnant women and children) in the research and to ensure that their interests are adequately protected. The ethics advisor should have expertise in research ethics in general and substantial experience in the assessment of ethics issues in the specific topic area of this project.An ethics report by ethics external advisor should be provided.
Pubblicazioni
Autori:
Japhet Kabalu Tshiongo, Lise Kuseke, Thierry Kalonji, Patrick Mitashi, Aimée Mupuala, Kassoum Kayentao, Trésor Zola Matuvanga, Vivi Maketa Tevuzula, Yann Kafala, Henk D.F.H. Schallig, Hypolite Muhindo Mavoko, Petra F. Mens
Pubblicato in:
International Journal of Infectious Diseases, 2025, ISSN 1201-9712
Editore:
Elsevier BV
DOI:
10.1016/J.IJID.2025.107927
Autori:
Japhet Kabalu Tshiongo, Lise Kuseke, Vivi Maketa Tevuzula, Flory Luzolo, Yann Kafala, Evodie Ngelesi, Moussa Djimde, Patrick Mitashi, Thierry Kalonji-Mukendi, Damien Mbanzulu Pita Nsonizau, Kassoum Kayentao, Petra F. Mens, Ryan van den Bos, Hypolite Muhindo Mavoko, Henk D. F. H. Schallig
Pubblicato in:
Paediatrics and International Child Health, 2025, ISSN 2046-9047
Editore:
Informa UK Limited
DOI:
10.1080/20469047.2025.2459964
Autori:
Wan-Yu Chu, Wietse M. Schouten, Hypolite Muhindo Mavoko, Japhet Kabalu Tshiongo, Doudou Malekita Yobi, Freddy-Arnold Kabasele, Gustave Kasereka, Vivi Maketa, Esperança Sevene, Anifa Vala, Jangsik Shi
Pubblicato in:
Clinical Pharmacokinetics, 2025, ISSN 0312-5963
Editore:
Springer Science and Business Media LLC
DOI:
10.1007/S40262-025-01581-6
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